Effect of fluticasone-impregnated throat packs on postoperative sore throat (POST) and hoarseness of voice: A randomized clinical trial

Background Post-operative sore throat (POST) is one of the most common complaints post-endotracheal intubation and can be decreased through various interventions. This study aimed to determine the effect of fluticasone-impregnated versus saline throat packs on the occurrence and severity of POST and voice hoarseness. Methods This prospective, randomized, double-blinded trial was conducted on patients undergoing nasosinus surgeries at Kasturba Medical College and Hospital. Patients were randomized to groups based on a computer-generated table of random numbers post-intubation after placing a definite length of oropharyngeal packs into group F (fluticasone) who received four puffs of fluticasone furoate-soaked throat packs and group C (control) wherein normal saline-soaked throat packs were used. Determining the incidence of POST and voice hoarseness was the primary outcome; severity of POST and voice hoarseness, patient satisfaction scores at 24 hours post-surgery and adverse events were secondary outcomes. Results Overall, 86 patients were randomized and 43 patients were included in each group. Incidence of POST (%) and voice hoarseness (%) were 55.8, 55.6, 55.8, 53.4 and 30.2, 28, 28, 28 in group C. Incidence of POST (%) and voice hoarseness (%) were 37.2, 37.2, 37.2, 34.8 and 14, 14, 14,14 in group F at 1, 2, 6 and 24 hours, respectively, however, the p values were not found to be significant at any time interval. There was no significant difference in terms of severity of POST and voice hoarseness, patient satisfaction scores between the groups and there were no reported adverse events. Conclusions In patients undergoing nasosinus surgery under general anesthesia with endotracheal intubation, fluticasone furoate-impregnated throat packs failed to show any significant reduction in the incidence and severity of POST as well as hoarseness of voice, and even though it was not statistically significant, the fluticasone impregnated group had higher patient satisfaction scores. Registration CTRI ( CTRI/2020/09/027946; 22/09/2020).

Overall, 86 patients were randomized and 43 patients were included in each group.Incidence of POST (%) and voice hoarseness (%) were 55. 8, 55.6, 55.8, 53.4 and 30.2, 28, 28, 28 in group C. Incidence of POST (%) and voice hoarseness (%) were 37.2, 37.2, 37.2, 34.8 and 14, 14, 14,14 in group F at 1, 2, 6 and 24 hours, respectively, however, the p values were not found to be significant at any time interval.There was no significant difference in terms of severity of POST and voice hoarseness, patient satisfaction scores between the groups and there were no reported adverse events.

Conclusions
In patients undergoing nasosinus surgery under general anesthesia with endotracheal intubation, fluticasone furoate-impregnated throat packs failed to show any significant reduction in the incidence and severity of POST as well as hoarseness of voice, and even though it was not statistically significant, the fluticasone impregnated group had higher patient satisfaction scores.

Introduction
Tracheal intubation is mostly performed under general anesthesia to secure the airway and is usually associated with variable degrees of trauma.2][3] Although clinicians often regard POST as a relatively minor complication it imparts a strongly negative influence on the overall experience of surgery and stay in the hospital postoperatively. 4POST is caused by a number of different factors, including vocal cord damage, congestive blood loss, and damage to the epithelium and mucosal cells caused by airway secretion. 58][9][10][11] Many surgical subspecialties use throat packs for various reasons.During surgery, they gather blood, secretions, and bone and cartilage fragments.It is asserted that doing so will lessen their inhalation and swallowing after surgery, which will lessen the likelihood of postoperative complications. 12Even though there are several advantages of inserting throat packs there are certain drawbacks and POST is major among them.Prior studies have revealed the significant influence of throat pack on postoperative sore throat. 13 reduce the frequency of POST, many interventions can be used, including the use of compact tracheal tubes, 14 using video laryngoscopy during intubation, 15 limiting endotracheal cuff pressure, 16 using steroids during surgery, [17][18][19] topically applying non-steroidal anti-inflammatory drugs (NSAIDs), 20 or using different gargles (magnesium and ketamine) during surgery. 21In pharmacological interventions aimed at enhancing the effectiveness of steroids, administration of dexamethasone at a dosage of 0.2 mg/kg has shown significant promise in reducing the occurrence of POST.In the case of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), notable prophylactic effects were observed with benzydamine treatment, exhibiting a risk ratio of 0.31.Additionally, the use of flurbiprofen lozenges at a dosage of 8.75 mg effectively mitigated the severity, though not the incidence of early POST.
In non-pharmacological interventions, the selection of tracheal tube size emerges as a pivotal factor in minimizing POST and ensuring optimal airway management during intubation.Recommended sizes range from 6.0-7.5 mm for females and 7.0-8.0mm for males.Excessive cuff pressure can lead to mucosal trauma and pressure-related injuries, consequently increasing the likelihood of POST occurrence.[24][25] The topical administration of nonsteroidal anti-inflammatory drugs, lidocaine, steroids, N-methyl-d-aspartate receptor antagonists, and Glycyrrhiza have all been used to prevent POST through various mechanisms of action, according to systematic reviews. 26Intranasal steroids are suitable for high drug concentrations in the nasal mucosa with minimal or no systemic side effects.Among intranasal steroids currently available, fluticasone exhibits the greatest affinity and selectivity for glucocorticoid receptors, along with the longest tissue retention.These distinct pharmacological traits make its robust anti-inflammatory effects at the intended site of action over other anti-inflammatory agents. 27wever, a thorough search of the literature showed no evidence of studies involving the use of throat packs soaked with steroid sprays. 28Prior clinical trials have shown good clinical efficacy of fluticasone furoate in patients with upper respiratory tract inflammation.As fluticasone furoate reduce the symptoms of upper respiratory tract inflammation, they could reduce POST without adverse effects.Thus, we need more qualified data on its effects to minimize POST which would be helpful to assess the improved management. 27r study drug, fluticasone furoate is typically available as a nasal spray and studies have not shown any adverse effects associated with the application of this spray.Therefore, the objective was to compare the effectiveness of fluticasoneimpregnated throat packs on the incidence and severity of POST and hoarseness of voice.

Trial design
Between September 2020 and July 2021, patients scheduled for nasosinus surgeries under general anesthesia with endotracheal intubation at Kasturba Medical College and Hospital participated in this prospective, 1:1 randomized, double-blinded clinical trial.After receiving approval from the Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee and registering with the CTRI, 86 patients were enrolled using the inclusion and exclusion criteria after providing written informed consent without any deviation from the original trial protocol and the trial was conducted according to the principles expressed in the Declaration of Helsinki.This study adheres to the CONSORT guidelines, and the proforma, model consent form and protocol can be found as Extended data. 46rticipants Participants classified as I or II according to the American Society of Anaesthesiologists (ASA) physical status classification, patients aged 18-60 years of both sexes were included in the study.Whereas those with a pre-existing sore throat and/or hoarseness of voice, anticipated difficult airway, already on steroids, requiring more than two attempts at endotracheal intubation and trauma during intubation were excluded.
Simple randomization with a 1:1 allocation ratio was carried out using an online randomization service.After patients had finished all baseline assessments and observer one had been blinded, sequentially numbered, opaque, and sealed envelopes were opened to reveal the allocation sequence.

Interventions
Patient preparation: On the morning of operation, all patients were given tab ranitidine 150 mg and tab metoclopramide 10 mg.Nil per oral orders of 6 hours for solids and 2 hours for clear fluids was advised.The patient was identified on the day of surgery, fasting status was confirmed and they were shifted to the operating room.The monitors included a 5-electrode ECG, a non-invasive blood pressure monitor, and a pulse oximeter before induction of anaesthesia.Baseline blood pressure, heart rate and peripheral oxygen saturation were noted.The intravenous line was secured with a suitable gauge intravenous catheter under aseptic precautions, and the Ringer's lactate infusion was started.
All the patients were pre-oxygenated for 3 minutes with 100% oxygen before being induced with intravenous 2 μg/kg fentanyl, induction with 2-3 mg/kg propofol, and neuromuscular blockade (NMB) with 0.1 mg/kg vecuronium.When the train-of-four count was zero, the patient was intubated under direct laryngoscopy (7 mm tube for females and 8 mm tube for males), which was inflated with air to a pressure of 25 mmHg.The demographic characteristics in terms of age, sex, BMI, smoking history and the mean duration of surgery were analyzed.
Observer one performed a preoperative evaluation and obtained informed consent.He was blinded to the group the patient was allotted.Additionally, he evaluated the patient after surgery and recorded the occurrence and severity of POST, voice hoarseness, and patient satisfaction score based on a predetermined score.Observer two performed the intubation and intervention according to the group allotted.Based on the group allocated, the patient received the throat pack soaked with either four puffs (400 mcg) of fluticasone furoate spray for group F and normal saline for group C. With the aid of Magill's forceps and direct laryngoscopy, packs with standard dimensions of 120 cm Â 7.5 cm were inserted.The use of steroids was avoided intraoperatively.Anesthesia was maintained with isoflurane, 40% oxygen and 60% air.Cuff pressure was kept below 25 cm H 2 O throughout the operation.In the end, the anesthetic agents were tapered and stopped, and 0.05 mg/kg of neostigmine was used to counter residual NMB.None of the patients received glycopyrrolate preoperatively or during the procedure.The throat pack was removed under direct laryngoscopy once the surgery was completed after gentle oral suctioning.Once the extubation criteria were satisfied, the patient was extubated and moved to the postoperative recovery room.

Parameters assessed
• Age, sex, BMI, smoking history and the mean duration of surgery were documented.
• Post-operative sore throat at 1 hour, 2 hours, 6 hours and 24 hours using a 4-point scale.
• Hoarseness of voice at 1 hour, 6 hours and 24 hours using a 4-point scale.
• Patient satisfaction score at 24 hours in the postoperative period.
Observer 1 interviewed patients at 1, 2, 6, and 24 hours to assess the incidence and severity of postoperative sore throat and hoarseness of voice, patient satisfaction level as well as any adverse events.

Postoperative assessment
The post-operative sore throat severity 18 was graded as follows: i) Grade 0, no sore throat at any time since the operation; ii) Grade 1, no pain, only discomfort or itchy sensation in the throat; iii) Grade 2, pain on swallowing or attempt at swallowing; and iv) Grade 3, pain at rest.
The severity of the hoarseness of voice 19 was graded as follows: i) Grade 0, no evidence of hoarseness of voice at any time since the operation; ii) Grade 1, no evidence of hoarseness at the time of the interview; iii) Grade 2, hoarseness at the time of interview noted by the patient only; and iv) Grade 3, hoarseness that is easily noted by the assessor at the time of the interview.

Outcomes
The primary outcome analyzed was the incidence of POST and post-operative voice hoarseness at 1, 2, 6 and 24 hours in both group C and group F. The secondary outcomes analyzed were severity of POST and voice hoarseness at 1, 2, 6 and 24 hours in both the groups including patient satisfaction scores at 24 hours post-surgery and any adverse events.

Blinding
Observer one was the principal investigator who did the preoperative evaluation, after checking suitability for inclusion criteria in the study and obtaining written informed consent.He was blinded to the group the patient was allotted.He explained to the patient about the study and assessed the patient postoperatively on their grade of postoperative sore throat, hoarseness of voice and patient satisfaction score according to a pre-existing scoring scale.
Observer two was the Consultant anaesthesiologist, who performed the laryngoscopy and intubation and performed the intervention according to the group allotted.

Statistical analysis
A pilot study with 10 patients in each group revealed that the control group had a 60% incidence of POST and the experimental group had a 40% incidence, which was used to determine the sample size.We required 96 patients in each group with a 20% difference between the two groups, assuming 85% power and a 5% level of significance.However, given the ongoing COVID-19 pandemic, due to a drastic reduction in the number of elective nasosinus surgeries in our institute, we were able to conduct our trial only in 86 patients (43 per group), despite extending our study period for three more months.For continuous variables, the data were presented as mean, and for categorical variables, as a percentage of frequency.To analyze significant differences between dichotomous variables, the chi-squared test was used.The term "p-value <0.05" denoted a statistically significant result.IBM SPSS Statistics (RRID:SCR_016479) 20.0 for Windows (SPSS Inc., Chicago, IL, US), a statistical software program, was used to conduct the statistical analysis.

Results
A total of 106 ASA I-II patients were screened in our study of which only 86 patients were included in our study.Of the 20 excluded, 11 patients required repeated attempts for intubation while nine required airway adjuncts (Figure 1).
There were 43 patients in each group and their demographic characteristics were comparable with no significant difference in terms of age, sex, and smoking history.The majority of patients in either group had ASA physical status II.The mean duration of surgery among both groups was also similar (Table 1).

Recruitment
Between September 2020 and July 2021, patients scheduled for nasosinus surgeries under general anesthesia with endotracheal intubation at Kasturba Medical College and Hospital participated in this prospective, 1:1 randomized, double-blinded clinical trial.2).Incidences of postoperative hoarseness of voice were found to be 30.2,28.0, 28.0 and 28.0% in group C at 1, 2, 6 and 24 hours and 14.0, 14.0, 14.0 and 14.0% in the group F at 1, 2, 6 and 24 hours, respectively (Table 2, Figure 3).Although there was a lower incidence of POST and hoarseness of voice in the fluticasone group at 1, 2, 6 and 24 hours, the p values were not found to be significant at any time interval.

Secondary outcomes
According to the criteria outlined in the methodology, the degree of POST and hoarseness of voice were graded.) who both had grade 3 hoarseness of voice.The difference between the groups was present, but it was not statistically significant (Table 3).Most of the patients in both groups had excellent patient satisfaction scores, however, patients in group F had higher satisfaction scores 24 hours postoperatively but were not statistically significant (Table 4).

Adverse events
Neither group experienced any adverse effects.

Discussion
Endotracheal intubation is the most definitive way of securing the airway.Many anesthesiologists consider POST, a frequent anesthetic complication, to be a minor complication.However, for some patients, it might be their initial complaint as soon as they regain consciousness, hence reduction of POST enhances postoperative patient comfort, satisfaction and overall hospital stay. 29In a prospective one-year follow-up study involving 5228 post-operative patients,   97.5% were reported dissatisfied, and in a cross-sectional study a prolonged hospital stay was associated in patients with POST due to naso-gastric tube insertion, blood-stained tracheal tubes. 30,31roat packs are used in oronasal procedures mainly to prevent intraoperative aspiration of blood into the respiratory and digestive tract.It is common knowledge that using pharyngeal packs makes recovery from surgery more painful and uncomfortable.POST brought on by oropharyngeal packs is unclear.It is postulated that the hard, abrasive cotton fibres of the pack can cause dryness of the surrounding tissues as well as the instrumentation per se can cause local inflammation eventually leading to POST and hoarseness of voice. 32Even though various pharmacological modalities of attenuating POST have been studied in the past [14][15][16][17][18][19][20][21] there is no extensive literature documenting the use of steroid-impregnated throat packs.Since steroids have an anti-inflammatory effect, we analyzed their effect in mitigating POST and hoarseness of voice.Patients with POST might benefit from a short course of low-to-moderate dose corticosteroids by lowering the inflammation of upper respiratory tract.Fluticasone is corticosteroid which can be used via oral, nasal and tropical route.
In 2016 fluticasone received FDA approval for upper respiratory allergy symptoms in adults and children over four years of age.Moreover, in comparison to other clinically used anti-inflammatory agents, fluticasone furoate enhanced receptor affinity and prolonged residence time in the tissue produce a more potent and prolonged anti-inflammatory effect at the target site. 27 prior studies, patient factors predicting POST included young age, being female and having a smoking history. 33,34autenbacher et al., 35 and Petrini et al., 36 revealed that older patients when compared to the younger age group had a lesser response to pain stimulus as ageing reduces pain sensitivity and intensity, thus suggesting young age as a predictor of POST.However, in our study, we found no difference among the groups as the majority of the patients in both groups were young.According to Feine et al., 37 women are more sensitive to the intensity of the pain and men typically have higher pain tolerance thresholds 28 suggesting that female patients tend to have a higher incidence of POST.Similar to the study by Jaensson et al., 38 who found no appreciable difference in POST incidence between men and women, there is no effect of sex on POST and hoarseness of voice in this study.Smoking is a significant predictor because it is known to cause airway inflammation on its own, 39,40 which contributes to POST, however, due to the small sample size in this study, we were unable to detect any influence on POST, which is similar to the study by Lee et al. 41 In the study by Higgins et al., 2 he found that the incidence of POST was higher in those with ASA physical status III when compared to those with ASA I/II (p≤0.05),however in our study all the patients had ASA status of I/II, thus no difference could be recorded.Longer surgery times have been shown in earlier studies 42,43 to affect the occurrence of POST, with factors including surgical manipulation of the airway and surrounding tissue, repeated suctioning, high anesthetic gas flow rates, and lack of airway humidity as contributors.However, in our study, there was no such difference because all of the patients were posted for nasosinus surgery and the surgical times in the two groups were comparable.
The overall incidence of POST and hoarseness of voice in our study was similar to the study done in 2017 on Korean patients by Lee et al., 41 wherein 207 patients were analyzed, among whom 119 patients (57.5%) developed POST and 80 patients (38.6%) developed hoarseness of voice.2][3][4] Even though the incidence of POST and hoarseness of voice was lower in the fluticasone group than in the control group in this study, there was never a postoperative difference that was statistically significant.This study is comparable to one by Park SY et al., 44 which compared the incidence of POST in patients with tracheal tubes impregnated with triamcinolone acetonide (n=72) and chlorhexidine (n=72) during intubation involving 150 patients who underwent elective laparoscopic cholecystectomy wherein the study design, patient populations, and interventions were almost similar to our study.His research demonstrated that when compared to the chlorhexidine group (71.8%; 51/72) the incidence of POST was significantly lower in the steroid-impregnated group (19.4%; 14/72) (p<0.001).
The overall severity of POST as well as hoarseness of voice was lower fluticasone group but was not statistically significant.These results are similar to the study by Park SY et al., 44 wherein the severity of POST was analyzed at 1, 6 and 24 hours and found that among 72 patients in the steroid-soaked throat pack group majority (68/72) had grade 0 severity at 1 hour and 24 hours and very few (10/72) had grade 1 severity of POST, which is similar to our study, however, their study revealed significant difference (p<0.001), which is unlike our study and probably can be explained by the small sample size in each group.
The majority of patients in this study reported positive experiences with fluticasone-impregnated throat packs when compared to the placebo group, but the findings were not statistically significant.The analysis of POST in 140 patients who needed intubation by Macintosh laryngoscope versus GlideScope in the study by Aqil M et al., 45 also included patient satisfaction scores at 24 hours following surgery, which was similar to our study.

Strength of the study
Randomized controlled trial design and accurate comparison of fluticasone-impregnated throat packs with saline throat packs on the incidence and severity of POST is considered to be strength of our study.

Limitations
This was a single center study with a relatively small sample size.Our study included only nasosinus surgeries and with respect to the endotracheal tube, the number of attempts, time taken for insertion and cuff pressure were not analyzed in this study.This single centered study may limit the generalizability of the findings.The relatively small sample size could have influenced the statistical significance of certain outcomes.The study exclusively focused on nasosinus surgeries, potentially limiting the extrapolation of results to other surgical procedures.Additionally, while the study addressed various aspects of endotracheal tube management, such as size and position, it did not analyze parameters such as the number of attempts, insertion time, or cuff pressure, which are also crucial factors in airway management but were beyond the scope of this investigation.

Generalisability
Randomized controlled trials (RCTs) provide the highest level of evidence.In this study we utilised the anti-inflammatory property of fluticasone furoate on reducing POST, which is one of the most disturbing after effects post-endotracheal intubation.Even though our study showed lesser incidence and severity of POST as well as hoarseness of voice it was not statistically significant, which might be due to small sample size in each group.Thus, after proving with an adequate sample size, our intervention could be applicable and would be beneficial in reducing the incidence of POST in patients undergoing endotracheal intubation.Multicenter studies with larger sample sizes exploring the impact of different surgical procedures on airway management outcomes are needed to provide valuable insights into optimizing patient care across various surgical specialties.Additionally, investigating the effectiveness of specific airway management techniques or devices, such as video laryngoscopy or alternative methods for endotracheal tube insertion, could further refine clinical practices.

Conclusions
The frequency and severity of POST and hoarseness of voice in patients undergoing nasosinus surgery under general anesthesia with endotracheal intubation were not significantly reduced by fluticasone furoate-impregnated throat packs.It gave a higher satisfaction score after 24 hours even though it was statistically insignificant.

Data availability
Underlying data Due to the fact that open posting of data on a repository was not included in the study information sheet at the time the study was done, data access will be granted once users have consented to the data sharing agreement and provided written plans and justification for what is proposed with the data.Data access may be obtained by submitting a request to the corresponding author.The study is well designed and executed.The background research is also commendable.If possible it would be better to continue patient enrolment to achieve the calculated sample size of 96 patients per group as it would possibly improve the power of the study and likely bring out a significant difference between the groups as there is a trend towards fluticasone decreasing the incidence of the primary outcome.

Extended data
The paragraph on secondary outcome needs some correction as the number of patients with grade 2 soreness is not mentioned appropriately, or has been missed.
Altogether the paper is well designed and reasonably well written but is underpowered to reveal the true benefits if any for the treatment being studied.

Is the work clearly and accurately presented and does it cite the current literature?
Partly

Is the study design appropriate and is the work technically sound? Yes
Are sufficient details of methods and analysis provided to allow replication by others?Yes If applicable, is the statistical analysis and its interpretation appropriate?Yes Are all the source data underlying the results available to ensure full reproducibility?Yes

Are the conclusions drawn adequately supported by the results? Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Neuro anaesthesia, Paediatric Anaesthesia, Intraoperative evoked potential monitoring I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Maharashtra, India
The introduction of the manuscript titled "Effect of fluticasone-impregnated throat packs on postoperative sore throat (POST) and hoarseness of voice: A randomized clinical trial" provides a comprehensive overview of the background, rationale, and objectives of the study.Overall, the introduction is well-structured and informative.However, here are some comments on potential flaws or areas for improvement: The introduction mentions the incidence of POST ranging from 12.1% to 70% and hoarseness from 4-43%.However, it would be helpful to provide the sources of these statistics to lend credibility to the claims.This is important for readers to evaluate the reliability and generalizability of the reported incidence rates.
The statement that POST is the eighth worst possible post-anesthesia effect is intriguing, but the source or reference for this specific ranking is not provided.Reviewer Expertise: Clinical Trial I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
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Figure 3 .
Figure 3. Incidence of postoperative hoarseness of voice.
While the introduction mentions that throat packs have advantages, it briefly touches on the drawbacks, with POST being a major concern.Expanding on the drawbacks and potential complications associated with throat packs could provide a more balanced view and help readers understand the context for investigating alternative interventions.The introduction discusses various interventions to reduce the frequency of POST, such as compact tracheal tubes, video laryngoscopy, cuff pressure control, steroids, NSAIDs, and different gargles.It might be beneficial to briefly mention the effectiveness or limitations of these interventions.The introduction mentions a thorough search of the literature showing no evidence of studies involving the use of throat packs soaked with steroid sprays.While this highlights the novelty of Is the work clearly and accurately presented and does it cite the current literature?Yes Is the study design appropriate and is the work technically sound?Yes Are sufficient details of methods and analysis provided to allow replication by others?Yes If applicable, is the statistical analysis and its interpretation appropriate?Yes Are all the source data underlying the results available to ensure full reproducibility?Yes Are the conclusions drawn adequately supported by the results?Yes Competing Interests: No competing interests were disclosed.
POST, Post-operative sore throat; Group C, Control group; Group F, Fluticasone group; CI, Confidence interval.

Table 4 .
Patient satisfaction score at 24 hours.
Group C, Control group; Group F, Fluticasone group.

Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Yes Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes
Competing Interests: No competing interests were disclosed.Reviewer Expertise: AIrway, resuscitation, Pain managementMathew George1 Amrita Institute of Medical Sciences and Research Centre, Kochi, India 2 Amrita Institute of Medical Sciences and Research Centre, Kochi, India